Optical stimulation systems with calibration and methods of making and using

ABSTRACT

An optical stimulation system includes a light source; an optical lead coupled, or coupleable, to the light source; at least one of a calibration table or a calibration formula, generated by a calibration procedure specifically using the light source and the optical lead of the optical stimulation system; and a control unit coupled, or coupleable, to the light source. The control module includes a memory to store the at least one of the calibration table or the calibration formula, and a processor coupled to the memory and configured for receiving a target light output level, using the at least one of the calibration table or the calibration formula to determine at least one operational parameter for generating the target light output level, and directing the light source, using the at least one operational parameter, to generate light at the target light output level.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is the U.S. national stage application of PCTApplication No. PCT/US19/22917, filed Mar. 19, 2019, which claims thebenefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent ApplicationSer. No. 62/647,561, filed Mar. 23, 2018, both of which are incorporatedherein by reference.

FIELD

The present disclosure is directed to the area of implantable opticalstimulation systems and methods of making and using the systems. Thepresent disclosure is also directed to implantable optical stimulationsystems utilizing a calibration table or calibration formula as well asmethods of making and using the optical stimulation systems.

BACKGROUND

Implantable optical stimulation systems can provide therapeutic benefitsin a variety of diseases and disorders. For example, optical stimulationcan be applied to the brain either externally or using an implantedstimulation lead to provide, for example, deep brain stimulation, totreat a variety of diseases or disorders. Optical stimulation may alsobe combined with electrical stimulation.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include a control module (for generatinglight or electrical signals sent to light sources in a lead), one ormore leads, and one or more light sources coupled to, or disposedwithin, each lead. The lead is positioned near the nerves, muscles,brain tissue, or other tissue to be stimulated.

BRIEF SUMMARY

In one aspect, an optical stimulation system includes a light source; anoptical lead coupled, or coupleable, to the light source; at least oneof a calibration table or a calibration formula, wherein the at leastone of the calibration table or the calibration formula is generated bya calibration procedure specifically using the light source and theoptical lead of the optical stimulation system; and a control unitcoupled, or coupleable, to the light source. The control module includesa memory to store the at least one of the calibration table or thecalibration formula, and a processor coupled to the memory andconfigured for receiving a target light output level, using the at leastone of the calibration table or the calibration formula to determine atleast one operational parameter for generating the target light outputlevel, and directing the light source, using the at least oneoperational parameter, to generate light at the target light outputlevel. In at least some aspects, the light source is part of the opticallead.

In at least some aspects, the optical stimulation system furtherincludes a light monitor coupled, or coupleable to, the control unit,wherein the optical lead further includes a first optical waveguide toreceive light generated by the light source and emit the light from adistal portion of the optical lead and a second optical waveguideconfigured to receive a portion of the light emitted from the distalportion of the optical lead and direct the received portion of the lightto the light monitor. In at least some aspects, the processor is furtherconfigured for receiving a measurement from the light monitor inresponse to generation of light at the optical output level; andcomparing the measurement to the target light output value. In at leastsome aspects, the processor is further configured for modifying the atleast one operational parameter based on the comparison between themeasurement and the target light output value.

In at least some aspects, the at least one of the calibration table orthe calibration formula includes a relationship between measurementvalues of the light monitor and light output values at the distalportion of the optical lead. In at least some aspects, the at least oneof the calibration table or the calibration formula includes arelationship between measurement values of the light monitor and valuesof the at least one operational parameter. In at least some aspects, theat least one operational parameter is an amplitude of signal provided tothe light source to generate the light. In at least some aspects, theprocessor is further configured for receiving a request for measurementof light output; directing the light monitor to measure the lightoutput; using the at least one of the calibration table or thecalibration formula to determine a light output level; and reporting thelight output value.

In at least some aspects, the at least one of the calibration table orthe calibration formula includes a relationship between light outputvalues at the distal portion of the optical lead and values of the atleast one operational parameter. In at least some aspects, the at leastone operational parameter is an amplitude of signal provided to thelight source to generate the light.

In another aspect, a non-transitory processor readable storage mediaincludes instructions for optical stimulation using an opticalstimulation system including a light source and an optical lead, whereinexecution of the instructions by one or more processor devices performsactions including receiving a target light output level; using the atleast one of a calibration table or a calibration formula to determineat least one operational parameter for generating the target lightoutput level, wherein the at least one of the calibration table or thecalibration formula is generated by a calibration procedure specificallyusing the light source and the optical lead of the optical stimulationsystem; and directing the light source, using the at least oneoperational parameter, to generate light at the target light outputlevel.

In a further aspect, a method for optical stimulation using an opticalstimulation system including a light source and an optical lead includesreceiving a target light output level; using the at least one of acalibration table or a calibration formula to determine at least oneoperational parameter for generating the target light output level,wherein the at least one of the calibration table or the calibrationformula is generated by a calibration procedure specifically using thelight source and the optical lead of the optical stimulation system; anddirecting the light source, using the at least one operationalparameter, to generate light at the target light output level.

In at least some aspects of the non-transitory processor readablestorage media or the method, the actions or steps further includereceiving a measurement from a light monitor in response to generationof light at the optical output level; and comparing the measurement tothe target light output value. In at least some aspects of thenon-transitory processor readable storage media or the method, theactions or steps further include modifying the at least one operationalparameter based on the comparison between the measurement and the targetlight output value.

In at least some aspects of the non-transitory processor readablestorage media or the method, the at least one of the calibration tableor the calibration formula includes a relationship between measurementvalues of the light monitor and light output values at the distalportion of the optical lead. In at least some aspects of thenon-transitory processor readable storage media or the method, the atleast one of the calibration table or the calibration formula includes arelationship between measurement values of the light monitor and valuesof the at least one operational parameter. In at least some aspects ofthe non-transitory processor readable storage media or the method, theat least one operational parameter is an amplitude of signal provided tothe light source to generate the light.

In yet another aspect, a method of calibrating an optical stimulationsystem including a light source and an optical lead includes generatinglight using the light source and different values of an operationalparameter; measuring a light output value for each of the differentvalues of the operational parameter; and generating at least one of acalibration table or a calibration formula for the optical stimulationsystem using the measured light output values and the different valuesof the operational parameter.

In at least some aspects, the operational parameter is an amplitude ofsignal provided to the light source to generate the light. In at leastsome aspects, the at least one of the calibration table or thecalibration formula includes a relationship between measurement valuesof the light monitor and light output values at the distal portion ofthe optical lead. In at least some aspects, the at least one of thecalibration table or the calibration formula includes a relationshipbetween measurement values of the light monitor and values of the atleast one operational parameter.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic overview of one embodiment of components of anoptical or optical/electrical stimulation system, including anelectronic subassembly;

FIG. 2 is a schematic side view of one embodiment of an arrangementincluding a light source, an optional light monitor, an optical lead,and a connector lead;

FIG. 3 is a schematic cross-sectional view of one embodiment of theoptical lead of FIG. 2 ;

FIG. 4A is a schematic side view of one embodiment of a control moduleconfigured to electrically couple to a lead or lead extension;

FIG. 4B is a schematic side view of one embodiment of a lead extensionconfigured to electrically couple a lead to the control module of FIG.4A;

FIG. 5 is a schematic side view of one embodiment of an electricalstimulation system that includes an electrical stimulation leadelectrically coupled to a control module;

FIG. 6 is a schematic side view of one embodiment of anoptical/electrical stimulation system with an optical/electricalstimulation lead coupled to a control module having a light source;

FIG. 7 is a schematic overview of one embodiment of components of aprogramming unit for an optical or optical/electrical stimulationsystem;

FIG. 8 is a flowchart of one embodiment of a method for generating acalibration table or calibration formula;

FIG. 9 is a flowchart of one embodiment of a method for using acalibration table or calibration formula for an optical stimulationsystem; and

FIG. 10 is a flowchart of one embodiment of another method for using acalibration table or calibration formula for an optical stimulationsystem.

DETAILED DESCRIPTION

The present disclosure is directed to the area of implantable opticalstimulation systems and methods of making and using the systems. Thepresent disclosure is also directed to implantable optical stimulationsystems utilizing a calibration table or calibration formula as well asmethods of making and using the optical stimulation systems.

In some embodiments, the implantable optical stimulation system onlyprovides optical stimulation. In other embodiments, the stimulationsystem can include both optical and electrical stimulation. In at leastsome of these embodiments, the optical stimulation system can be amodification of an electrical stimulation system to also, or instead,provide optical stimulation. Optical stimulation may include, but is notnecessarily limited to, stimulation resulting from response toparticular wavelengths or wavelength ranges of light or from thermaleffects generated using light or any combination thereof.

FIG. 1 is a schematic overview of one embodiment of components of anoptical stimulation system 100 (or combination optical/electricalstimulation system) including an electronic subassembly 110 disposedwithin a control module (for example, an implantable or external pulsegenerator or implantable or external light generator). It will beunderstood that the optical stimulation system can include more, fewer,or different components and can have a variety of differentconfigurations including those configurations disclosed in thestimulator references cited herein. In at least some embodiments, theoptical stimulation system may also be capable of providing electricalstimulation through optional electrodes 126.

In at least some embodiments, selected components (for example, a powersource 112, an antenna 118, a receiver 102, a processor 104, and amemory 105) of the optical stimulation system can be positioned on oneor more circuit boards or similar carriers within a sealed housing of acontrol module. Any suitable processor 104 can be used and can be assimple as an electronic device that, for example, produces signals todirect or generate optical stimulation at a regular interval or theprocessor can be capable of receiving and interpreting instructions froman external programming unit 108 that, for example, allows modificationof stimulation parameters or characteristics.

The processor 104 is generally included to control the timing and othercharacteristics of the optical stimulation system. For example, theprocessor 104 can, if desired, control one or more of the timing, pulsefrequency, amplitude, and duration of the optical stimulation. Inaddition, the processor 104 can select one or more of the optionalelectrodes 126 to provide electrical stimulation, if desired. In someembodiments, the processor 104 selects which of the optionalelectrode(s) are cathodes and which electrode(s) are anodes.

Any suitable memory 105 can be used. The memory 105 illustrates a typeof computer-readable media, namely computer-readable storage media.Computer-readable storage media may include, but is not limited to,nonvolatile, non-transitory, removable, and non-removable mediaimplemented in any method or technology for storage of information, suchas computer readable instructions, data structures, program modules, orother data. Examples of computer-readable storage media include RAM,ROM, EEPROM, flash memory, or other memory technology, magnetic storagedevices, or any other medium which can be used to store the desiredinformation and which can be accessed by a processor.

The processor 104 is coupled to a light source 120. Any suitable lightsource can be used including, but not limited to, light emitting diodes(LEDs), organic light emitting diodes (OLEDs), laser diodes, lamps,light bulbs, or the like or any combination thereof. In at least someembodiments, the optical stimulation system may include multiple lightsources. In at least some embodiments, each of the multiple lightsources may emit light having a different wavelength or differentwavelength range. Any suitable wavelength or wavelength range can beused including, but not limited to, visible, near infrared, andultraviolet wavelengths or wavelength ranges. In at least someembodiments, the optical stimulation system includes a light source thatemits in the orange, red, or infrared wavelength ranges (for example, inthe range of 600 to 1200 nm or in the range of 600 to 700 nm or in therange of 610 to 650 nm or 620 nm or the like.) In at least someembodiments, the optical stimulation system includes a light source thatemits in the green or blue wavelength ranges (for example, in the rangeof 450 to 550 nm or in the range of 495 to 545 nm or the like.) Awavelength or wavelength range of a light source may be selected toobtain a specific therapeutic, chemical, or biological effect.

As described below, the light source 120 may be disposed within thecontrol module or disposed external to the control module such as, forexample, in a separate unit or module or as part of an optical lead. Theprocessor 104 provides electrical signals to operate the light source120 including, for example, directing or driving the generation of lightby the light source, pulsing the light source, or the like. For example,the processor 104 can direct current from the power source 112 tooperate the light source 120. In at least some embodiments, the lightsource 120 is coupled to one or more optical waveguides (such as anoptical fiber or other optical transmission media) disposed in anoptical lead 122. In at least some embodiments, the optical lead 122 isarranged so that one or more of the optical waveguides emits light fromthe distal portion of the optical lead (for example, the distal end orat one or more positions along the distal portion of the lead or anycombination thereof).

Optionally, the processor 104 is also coupled to a light monitor 124that is used to monitor or measure light from the light source 122. Forexample, the light monitor 124 can produce electrical or other signalsin response to the light received by the light monitor. Any suitablelight monitor 124 can be used including, but not limited to,photodiodes, phototransistors, photomultipliers, charge coupled devices(CCDs), light dependent resistors (LRDs), photo-emissive cells,photo-conductive ells, photo-voltaic cells, photo-junction devices, orthe like or any combination thereof. The light monitor 124 may be usedto measure or monitor the light emitted by the light source 120 or fromthe optical waveguide(s) (or other optical transmission media) of theoptical lead 122. In at least some embodiments, the light monitor 124may be coupled to one or more optical waveguides (or other opticaltransmission media) of the optical lead 122 to transmit the light alongan optical lead for measurement or monitoring.

Any power source 112 can be used including, for example, a battery suchas a primary battery or a rechargeable battery. Examples of other powersources include super capacitors, nuclear or atomic batteries, fuelcells, mechanical resonators, infrared collectors, flexural poweredenergy sources, thermally-powered energy sources, bioenergy powersources, bioelectric cells, osmotic pressure pumps, and the like. Asanother alternative, power can be supplied by an external power sourcethrough inductive coupling via an antenna 118 or a secondary antenna.The external power source can be in a device that is mounted on the skinof the user or in a unit that is provided near the user on a permanentor periodic basis. In at least some embodiments, if the power source 112is a rechargeable battery, the battery may be recharged using theantenna 118 and a recharging unit 116. In some embodiments, power can beprovided to the battery for recharging by inductively coupling thebattery to the external recharging unit 116.

In at least some embodiments, the processor 104 is coupled to a receiver102 which, in turn, is coupled to an antenna 118. This allows theprocessor 104 to receive instructions from an external source, such asprogramming unit 108, to, for example, direct the stimulation parametersand characteristics. The signals sent to the processor 104 via theantenna 118 and the receiver 102 can be used to modify or otherwisedirect the operation of the optical stimulation system. For example, thesignals may be used to modify the stimulation characteristics of theoptical stimulation system such as modifying one or more of stimulationduration and stimulation amplitude. The signals may also direct theoptical stimulation system 100 to cease operation, to start operation,to start charging the battery, or to stop charging the battery. In otherembodiments, the stimulation system does not include the antenna 118 orreceiver 102 and the processor 104 operates as initially programmed.

In at least some embodiments, the antenna 118 is capable of receivingsignals (e.g., RF signals) from an external programming unit 108 (suchas a clinician programmer or patient remote control or any other device)which can be programmed by a user, a clinician, or other individual. Theprogramming unit 108 can be any unit that can provide information orinstructions to the optical stimulation system 100. In at least someembodiments, the programming unit 108 can provide signals or informationto the processor 104 via a wireless or wired connection. One example ofa suitable programming unit is a clinician programmer or other computeroperated by a clinician or other user to select, set, or programoperational parameters for the stimulation. Another example of theprogramming unit 108 is a remote control such as, for example, a devicethat is worn on the skin of the user or can be carried by the user andcan have a form similar to a pager, cellular phone, or remote control,if desired. In at least some embodiments, a remote control used by apatient may have fewer options or capabilities for altering stimulationparameters than a clinician programmer.

Optionally, the optical stimulation system 100 may include a transmitter(not shown) coupled to the processor 104 and the antenna 118 fortransmitting signals back to the programming unit 108 or another unitcapable of receiving the signals. For example, the optical stimulationsystem 100 may transmit signals indicating whether the opticalstimulation system 100 is operating properly or not or indicating whenthe battery needs to be charged or the level of charge remaining in thebattery. The processor 104 may also be capable of transmittinginformation about the stimulation characteristics so that a user orclinician can determine or verify the characteristics.

FIG. 2 illustrates one embodiment of an arrangement 200 for an opticalstimulation system that can be used with a control module (see, FIG. 4). In at least some embodiments, the control module may be originallydesigned for use with an electrical stimulation system and adapted foruse as an optical stimulation system via the arrangement 200.

The arrangement 200 includes a base unit 228 a light source 120 disposedin a housing 230, an optical lead 122 with one or more emission regions232 a, 232 b of a distal portion from which light is emitted, and aconnector lead 234 with one or more terminals 236 for coupling to acontrol module or lead extension, as described below. The optical lead122 and connector lead 234, independently, may be permanently, orremovably, coupled to the base unit 228. If removably coupleable to thebase unit 228, the optical lead 122, connector lead 234, or both willhave corresponding arrangements (for example, terminals and contacts)for transmission of light (for the optical lead) or electrical signals(for the connector lead) to the base unit 228. The one or more emissionregions 232 a, 232 b may include a tip emission region 232 a that emitsdistally away from the lead or may include a side emission regions 232 bthat emit at the sides of the lead or any combination thereof.

In addition to the light source 120, the base unit 228 can optionallyinclude a light monitor 124. The base unit 228 may also includecomponents such as electrical components associated with the lightsource 120 or light monitor 124, a heat sink, optical components (forexample, a lens, polarizer, filter, or the like), a light shield toreduce or prevent light emission out of the housing of the base unit orto reduce or prevent extraneous light from penetrating to the lightmonitor 124 or the like. The housing 230 of the base unit 228 can bemade of any suitable material including, but not limited to, plastic,metal, ceramic, or the like, or any combination thereof. If the baseunit 228 is to be implanted, the housing 230 is preferably made of abiocompatible material such as, for example, silicone, polyurethane,titanium or titanium alloy, or any combination thereof.

In at least some embodiments, the optical lead 122, as illustrated incross-section in Figured 3, includes a lead body 241 and one or moreoptical waveguides 238 (or other optical transmission media) fortransmission of light from the light source 120 with emission along theone or more emission regions 232 a, 232 b disposed on the distal portionof the optical lead. In the illustrated embodiment, the light is emittedat the distal tip of the lead. In other embodiments, the light may beemitted at one or more points along the length of at least the distalportion of the lead. In some embodiments with multiple light sources,there may be separate optical waveguides for each light source or lightfrom multiple light sources may be transmitted along the same opticalwaveguide(s). The optical lead 122 may also include one or more opticalcomponents, such as a lens, diffuser, polarizer, filter, or the like, atthe distal portion of the lead (for example, at the terminal end of theoptical waveguide 238) to modify the light transmitted through theoptical waveguide.

In at least some embodiments that include a light monitor 124, theoptical lead 122 may include one or more optical waveguides 240 (orother optical transmission media) that receive light emitted from thelight source 120 and transmitted by the optical waveguide 238 in orderto measure or monitor the light emitted at the one or more emissionregions 232 a, 232 b of the optical lead. The optical waveguide(s) 240transmit light from the one or more emission regions 232 a, 232 b of theoptical lead to the light monitor 124 in the base unit 228. The opticallead 122 may also include one or more optical components, such as alens, diffuser, polarizer, filter, or the like, at the distal portion ofthe lead (for example, at the terminal end of the optical waveguide 240)to modify the light received by the optical waveguide(s) 240.

The connector lead 234 includes conductors (e.g., wires—not shown)disposed in a lead body extending along the connector lead 234 to theterminals 236 on the proximal end of the connector lead. As analternative, the connector lead 234 may be permanently attached to acontrol module or other device where the conductors then attach tocontact points within the control module or other device. The conductorscarry electrical signals to the base unit 228 and the light source 120and, optionally, other electrical components in the base unit foroperation of the light source 120. The conductors may also carryelectrical signals from the optional light monitor 124 in the base unit228 to the control module or other device. These electrical signals maybe generated by the light monitor 124 in response to light received bythe light monitor.

FIG. 4A is a schematic side view of one embodiment of proximal ends 442of one or more leads (for example, connector lead 234 of FIG. 2 ) orlead extensions 460 (see, FIG. 4B) coupling to a control module 446 (orother device) through one or more control module connectors 444. The oneor more proximal ends 442 include terminals 448 (for example, terminals236 of connector lead 234).

The control module connector 444 defines at least one port 450 a, 450 binto which a proximal end 442 can be inserted, as shown by directionalarrows 452 a and 452 b. The control module 446 (or other device) candefine any suitable number of ports including, for example, one, two,three, four, five, six, seven, eight, or more ports.

The control module connector 444 also includes a plurality of connectorcontacts, such as connector contact 454, disposed within each port 450 aand 450 b. When the proximal end 442 is inserted into the ports 450 aand 450 b, the connector contacts 454 can be aligned with a plurality ofterminals 448 disposed along the proximal end(s) 442. Examples ofconnectors in control modules are found in, for example, U.S. Pat. Nos.7,244,150 and 8,224,450, which are incorporated by reference.

The control module 446 typically includes a connector housing 445 and asealed electronics housing 447. An electronic subassembly 110 (see, FIG.1 ) and an optional power source 112 (see, FIG. 1 ) are disposed in theelectronics housing 447.

FIG. 4B is a schematic side view of a portion of another embodiment ofan optical stimulation system 100. The optical stimulation system 100includes a lead extension 460 that is configured to couple one or moreproximal ends 442 of a lead to the control module 446. In FIG. 4B, thelead extension 460 is shown coupled to a single port 450 defined in thecontrol module connector 444. Additionally, the lead extension 460 isshown configured to couple to a single proximal end 442 of a lead (forexample, the connector lead 234 of FIG. 2 ).

A lead extension connector 462 is disposed on the lead extension 460. InFIG. 4B, the lead extension connector 462 is shown disposed at a distalend 464 of the lead extension 460. The lead extension connector 462includes a connector housing 466. The connector housing 466 defines atleast one port 468 into which terminals 448 of the proximal end 442 ofthe lead can be inserted, as shown by directional arrow 470. Theconnector housing 466 also includes a plurality of connector contacts,such as connector contact 472. When the proximal end 442 is insertedinto the port 468, the connector contacts 472 disposed in the connectorhousing 466 can be aligned with the terminals 448 for electricalcoupling.

In at least some embodiments, the proximal end 474 of the lead extension460 is similarly configured as a proximal end 442 of a lead. The leadextension 460 may include a plurality of electrically conductive wires(not shown) that electrically couple the connector contacts 472 to aproximal end 474 of the lead extension 460 that is opposite to thedistal end 464. In at least some embodiments, the conductive wiresdisposed in the lead extension 460 can be electrically coupled to aplurality of terminals (not shown) disposed along the proximal end 474of the lead extension 460. In at least some embodiments, the proximalend 474 of the lead extension 460 is configured for insertion into aconnector disposed in another lead extension (or another intermediatedevice). In other embodiments (and as shown in FIG. 4B), the proximalend 474 of the lead extension 460 is configured for insertion into thecontrol module connector 144.

In some embodiments, the optical stimulation system may also be anelectrical stimulation system. FIG. 5 illustrates schematically oneembodiment of an electrical stimulation system 500. The electricalstimulation system includes a control module 446 (e.g., a stimulator orpulse generator) and an electrical stimulation lead 580 coupleable tothe control module 446. The same control module 446 can be utilized withthe arrangement 200 (FIG. 2 ) for optical stimulation and an electricalstimulation lead 580. With respect to the optical/electrical stimulationsystem of FIG. 1 , the control module 446 can include the electronicsubassembly 110 (FIG. 1 ) and power source 112 (FIG. 1 ) and theelectrical stimulation lead 580 can include the electrodes 126. Theoptical arrangement 200 of FIG. 2 can be inserted into another port ofthe control module 446.

The lead 580 includes one or more lead bodies 582, an array ofelectrodes 583, such as electrode 126, and an array of terminals (e.g.,448 in FIG. 4A-4B) disposed along the one or more lead bodies 582. In atleast some embodiments, the lead is isodiametric along a longitudinallength of the lead body 582. Electrically conductive wires, cables, orthe like (not shown) extend from the terminals to the electrodes 126.Typically, one or more electrodes 126 are electrically coupled to eachterminal. In at least some embodiments, each terminal is only connectedto one electrode 126.

The lead 580 can be coupled to the control module 446 in any suitablemanner. In at least some embodiments, the lead 580 couples directly tothe control module 446. In at least some other embodiments, the lead 580couples to the control module 446 via one or more intermediate devices.For example, in at least some embodiments one or more lead extensions460 (see e.g., FIG. 4B) can be disposed between the lead 580 and thecontrol module 446 to extend the distance between the lead 580 and thecontrol module 446. Other intermediate devices may be used in additionto, or in lieu of, one or more lead extensions including, for example, asplitter, an adaptor, or the like or combinations thereof. It will beunderstood that, in the case where the electrical stimulation system 500includes multiple elongated devices disposed between the lead 580 andthe control module 446, the intermediate devices may be configured intoany suitable arrangement.

The electrical stimulation system or components of the electricalstimulation system, including one or more of the lead bodies 582 and thecontrol module 446, are typically implanted into the body of a patient.The electrical stimulation system can be used for a variety ofapplications including, but not limited to, brain stimulation, neuralstimulation, spinal cord stimulation, muscle stimulation, and the like.

The electrodes 126 can be formed using any conductive, biocompatiblematerial. Examples of suitable materials include metals, alloys,conductive polymers, conductive carbon, and the like, as well ascombinations thereof. In at least some embodiments, one or more of theelectrodes 126 are formed from one or more of: platinum, platinumiridium, palladium, palladium rhodium, or titanium. The number ofelectrodes 126 in each array 583 may vary. For example, there can betwo, four, six, eight, ten, twelve, fourteen, sixteen, or moreelectrodes 126. As will be recognized, other numbers of electrodes 126may also be used.

Examples of electrical stimulation systems with leads are found in, forexample, U.S. Pat. Nos. 6,181,969; 6,295,944; 6,391,985; 6,516,227;6,609,029; 6,609,032; 6,741,892; 7,244,150; 7,450,997; 7,672,734;7,761,165; 7,783,359; 7,792,590; 7,809,446; 7,949,395; 7,974,706;8,831,742; 8,688,235; 6,175,710; 6,224,450; 6,271,094; 6,295,944;6,364,278; and 6,391,985; U.S. Patent Applications Publication Nos.2007/0150036; 2009/0187222; 2009/0276021; 2010/0076535; 2010/0268298;2011/0004267; 2011/0078900; 2011/0130817; 2011/0130818; 2011/0238129;2011/0313500; 2012/0016378; 2012/0046710; 2012/0071949; 2012/0165911;2012/0197375; 2012/0203316; 2012/0203320; 2012/0203321; 2012/0316615;2013/0105071; 2011/0005069; 2010/0268298; 2011/0130817; 2011/0130818;2011/0078900; 2011/0238129; 2011/0313500; 2012/0016378; 2012/0046710;2012/0165911; 2012/0197375; 2012/0203316; 2012/0203320; and2012/0203321, all of which are incorporated by reference in theirentireties.

FIG. 6 illustrates other optional embodiments. For example, FIG. 6illustrates one embodiment of an optical/electrical stimulation system100 with a lead 690 with both electrodes 126 and an optical waveguidethat emits light from the from one more emission regions 232 a, 232 b ofthe lead. In some embodiments, the lead 690 can be coupled to the baseunit 228 and connector lead 234 of FIG. 2 with conductors (andoptionally connector contacts if the lead 690 or connector lead 234 areremovable from the base unit 228) electrically coupling the terminals236 of the connector lead to the electrodes 126 of the lead 690.

FIG. 6 also illustrates one embodiment of a control module 446 that alsoincludes a light source 120 within the control module. Such anarrangement can replace the base unit 228 and connector lead 234 of FIG.2 and may include a lead extension 460.

FIG. 7 illustrates one embodiment of a programming unit 108. Theprogramming unit 108 can include a computing device 700 or any othersimilar device that includes a processor 702 and a memory 704, a display706, and an input device 708.

The computing device 700 can be a computer, tablet, mobile device, orany other suitable device for processing information or programming anoptical stimulation system. The computing device 700 can be local to theuser or can include components that are non-local to the computerincluding one or both of the processor 702 or memory 704 (or portionsthereof). For example, in at least some embodiments, the user mayoperate a terminal that is connected to a non-local computing device. Inother embodiments, the memory can be non-local to the user.

The computing device 700 can utilize any suitable processor 702including at least one hardware processors that may be local to the useror non-local to the user or other components of the computing device.The processor 702 is configured to execute instructions provided to theprocessor 702, as described below.

Any suitable memory 704 can be used for the computing device 702. Thememory 704 illustrates a type of computer-readable media, namelycomputer-readable storage media. Computer-readable storage media mayinclude, but is not limited to, nonvolatile, non-transitory, removable,and non-removable media implemented in any method or technology forstorage of information, such as computer readable instructions, datastructures, program modules, or other data. Examples ofcomputer-readable storage media include RAM, ROM, EEPROM, flash memory,or other memory technology, CD-ROM, digital versatile disks (“DVD”) orother optical storage, magnetic cassettes, magnetic tape, magnetic diskstorage or other magnetic storage devices, or any other medium which canbe used to store the desired information and which can be accessed by acomputing device.

Communication methods provide another type of computer readable media;namely communication media. Communication media typically embodiescomputer-readable instructions, data structures, program modules, orother data in a modulated data signal such as a carrier wave, datasignal, or other transport mechanism and include any informationdelivery media. The terms “modulated data signal,” and “carrier-wavesignal” includes a signal that has at least one of its characteristicsset or changed in such a manner as to encode information, instructions,data, and the like, in the signal. By way of example, communicationmedia includes wired media such as twisted pair, coaxial cable, fiberoptics, wave guides, and other wired media and wireless media such asacoustic, RF, infrared, and other wireless media.

The display 706 can be any suitable display device, such as a monitor,screen, display, or the like, and can include a printer. In at leastsome embodiments, the display 706 may form a single unit with thecomputing device 700. The input device 708 can be, for example, akeyboard, mouse, touch screen, track ball, joystick, voice recognitionsystem, or any combination thereof, or the like.

The methods and systems described herein may be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein. Accordingly, the methods and systemsdescribed herein may take the form of an entirely hardware embodiment,an entirely software embodiment or an embodiment combining software andhardware aspects. Systems referenced herein typically include memory andtypically include methods for communication with other devices includingmobile devices. Methods of communication can include both wired andwireless (for example, RF, optical, or infrared) communications methodsand such methods provide another type of computer readable media; namelycommunication media. Wired communication can include communication overa twisted pair, coaxial cable, fiber optics, wave guides, or the like,or any combination thereof. Wireless communication can include RF,infrared, acoustic, near field communication, Bluetooth™, or the like,or any combination thereof.

This optical power output by the light source 120 is often differentfrom the optical power output at the distal end of the optical lead. Forexample, the components in the light source 120 and optical lead 122, aswell as the manufacturing process, produce light losses from the opticalpower output at the distal end of the optical lead. Moreover, theindividual light sources and optional light monitors, as well as otheroptical components such as the optical waveguides, generally havevariations of performance from part to part. In addition, the powersource 112 can have an associated tolerance and can vary betweenindividual units.

To provide more uniform controlled output for therapy, an opticalstimulation system can include a mechanism to provide calibration forthe system. In at least some embodiments, a user may be allowed toprogram custom calibrations of the optical stimulation system (orcomponents of the optical stimulation system) dynamically when thesystem is implanted into the patient, or before. In at least someembodiments, calibration of optical energy output can be performedduring, or subsequent to, manufacturing. In at least some embodimentswhere the power source and the light source (or other opticalcomponents) are independently manufactured, multiple components can beindividually calibrated and may be packaged together with a combinedcalibration.

In at least some embodiments, one or more calibration tables orcalibration formulas can be stored in the memory 105 of the opticalstimulation system 100 (for example, a memory within the control module446 or the memory 704 of a programming unit 108). When more than onecalibration table or calibration formula is present, each calibrationtable or calibration formula may be related to different ranges ofvalues or to different operating conditions or different components orany combination thereof. A calibration formula may be linear ornon-linear. A non-linear calibration formula may include quadratic;third-, fourth-, or higher-order polynomial; exponential; logarithmic;or any other suitable terms. A calibration formula may also take theform of a coded routine with heuristic rules or instructions.

In at least some embodiments, the calibration table or calibrationformula presents a relationship between measurement values of the lightmonitor 124 and light output values at the distal portion of the opticallead 122. For example, the calibration table or calibration formula mayrelate measurements of the light monitor in mA or mV (or other suitableunits) to light output at the distal portion of the optical lead in mW(or other suitable units.) In at least some embodiments, the calibrationtable or the calibration formula presents a relationship betweenmeasurement values of the light monitor 124 and values of at least oneoperational parameter such as, for example, amplitude (e.g., current orvoltage amplitude) of the signal driving the light source 120. In atleast some embodiments, the calibration table or calibration formulapresents a relationship between measurement values of the light monitor124 and light output values of the light source 120.

The examples of calibration tables and calibration formulas presented inthe preceding paragraph utilize one input parameter. It will beunderstood, however, that other suitable calibration tables andcalibration formulas may include multiple input parameters (for example,light output value and amplitude of a signal driving the light source.)

In some embodiments, the calibration table or formula may alsoincorporate absorption and diffusion coefficients (μa and μd) for thetissues as well as the CSF. For example, the calibration table orformula may estimate a light intensity value received by target tissueafter emission from the optical lead and travel through interveningtissue. Preferably, the distance from the emission site on the opticallead to the target tissue site would be known or estimated. This couldlead to a patient specific model for dose optimization.

In some embodiments, the calibration table(s) or calibration formula(s)are stored on a memory 105 of a control module 446. The calibrationtable(s) or calibration formula(s) may be provided to the memory 105 inany suitable manner. For example, the calibration table(s) orcalibration formula(s) may be stored on the memory 105 during, or after,manufacture of the control module. As another example, the calibrationtable(s) or calibration formula(s) may be stored on a memory in the baseunit 228 or other portion of the arrangement 200 and downloaded orotherwise provided to, or accessed by, the memory 105 or processor 104when the arrangement 200 is coupled to the control module 446. As analternative, the base unit 228 can include an electrical component, suchas a resistor, that can be measured to provide a calibration value or anindex for selection of a calibration table or calibration formula from aset of calibration tables or calibration formulas. As yet anotherexample, the calibration table(s) or calibration formula(s) may resideon the programming unit 108 or other external device and downloaded orotherwise provided or accessed by the memory 105 or processor 104through communication with the programming unit or other externaldevice. As a further embodiment, the calibration table(s) or calibrationformula(s) may be input by a user (e.g., a clinician, a programmer, or apatient) during a programming or other session. In at least someembodiments, a calibration table or calibration formula may be passwordprotected or otherwise limited to use by authorized individuals.

In some embodiments, the calibration table(s) or calibration formula(s)are stored on a memory 704 of a programming unit 108. The calibrationtable(s) or calibration formula(s) may be provided to the memory 704 inany suitable manner. For example, the calibration table(s) orcalibration formula(s) may be stored on the memory 704 during, or after,manufacture of the programming unit. As another example, the calibrationtable(s) or calibration formula(s) may be stored on a memory in thecontrol module 446 or base unit 228 or other portion of the arrangement200 and downloaded or otherwise provided to, or accessed by, the memory704 of the programming unit. As a further embodiment, the calibrationtable(s) or calibration formula(s) may be input by a user (e.g., aclinician, a programmer, or a patient) during a programming or othersession. In at least some embodiments, a calibration table orcalibration formula may be password protected or otherwise limited touse by authorized individuals.

FIG. 8 illustrates one embodiment of a method for generating acalibration table or calibration formula. This method can be performedat any suitable point during the manufacture or subsequent use of theoptical stimulation system. For example, the method may be performedafter manufacture of the optical arrangement 200 of FIG. 2 at the siteof manufacture or elsewhere. As another example, the method may beperformed prior to implantation in the patient at the site ofimplantation or at some site of preparation of the optical stimulationsystem. In at least some embodiments, the calibration table(s) orcalibration formula(s) are not determined until the optical arrangement200 is associated with a particular control module.

In step 802, an optical arrangement, such as optical arrangement 200 ofFIG. 2 , is provided. In some embodiments, only the light source 120 orthe base unit 228 is provided. In other embodiments, the base unit 228and the optical lead 122 are provided. In at least some embodiments, acontrol module is also provided. The control module may be theparticular control module that will be implanted with the arrangement200; in other instances, the control module may be the same type ofcontrol module that is intended for use with the arrangement 200; in yetother instances, the control module may be any suitable control module.

In step 804, light is generated using the optical arrangement 200 anddifferent values of an operational parameter (for example, current orvoltage amplitude) or for different values of output optical power ofthe light source 120. In step 806, the light output values are measuredfor each instance of light that is generated. These light output valuesmay be measured at the output of the optical lead 122 or output of thelight source 120 or at any other suitable location. In some embodimentsthat include a light monitor 124 in the optical arrangement 200, thelight output values may be measured using the light monitor. In at leastsome embodiments, the optical lead 122 or the distal end of the opticallead may be placed in a material that simulates patient tissue to bettersimulate conditions of use of the lead.

In step 808, the calibration table or calibration formula is generatedfrom the measurements. In at least some embodiments, a calibration tablemay include entries that are extrapolated or interpolated from themeasurements. Any suitable method for obtaining these entries can beused including, but not limited to, nearest-neighbor methods, piece-wiselinear methods, spline methods, or other linear or non-linearextrapolation or interpolation methods. Similarly, a calibration formulacan be generated by any suitable linear or non-linear extrapolation orinterpolation methods. In at least some embodiments, the calibrationtable or calibration formula will allow for non-linear interpolation orextrapolation.

In at least some embodiments, the calibration table(s) or calibrationformula(s) is automatically stored on the base unit 228, control module446, or programming unit 108, or any combination thereof. In at leastsome embodiments, a user or device can input the calibration table(s) orcalibration formula(s) into the base unit 228, control module 446, orprogramming unit 108, or any combination thereof

FIG. 9 illustrates one embodiment of a method for using calibrationtable(s) or calibration formula(s). As described above, the calibrationtable(s) or calibration formula(s) may be stored on the control module,programming unit, or elsewhere. In step 902, a target light output valueis provided. The light output value may be for the output of the opticallead 122 or the output of the light source 120 or at any other suitablelocation. In at least some embodiments, the target light output value isprovided by a user, such as a clinician, programmer, or patient. In atleast some embodiments, the target light output value may be provided bythe system or other device. For example, the system may utilize afeedback loop to modify the output and automatically provide a lightoutput value.

In step 904, the calibration table(s) or calibration formula(s) is usedto determine one or more operational parameters (for example, a currentor voltage amplitude) to produce the target light output value accordingto the calibration table(s) or calibration formula(s). In at least someembodiments using a calibration table(s), for light output values thatare not provided on the table, linear or non-linear interpolation orextrapolation techniques can be used to determine the operationalparameter(s).

In step 906, light is generated using the determined operationalparameter(s). In optional step 908, the light output value of thegenerated light can be measured using, for example, the light monitor124. If the light output value differs from the target light outputvalue by a threshold amount, the system or user may modify theoperational parameter(s). Optionally, step 908 may be performed again todetermine whether the actual light output value corresponds, within athreshold amount, to the target output value.

FIG. 10 illustrates another embodiment of a method for using calibrationtable(s) or calibration formula(s). As described above, the calibrationtable(s) or calibration formula(s) may be used to calibrate ameasurement of light output (for example, in mA or mV) by the lightmonitor 124 to a light output value (for example, in mW.) In step 1002,a request for measurement of light output is received. The light outputmeasurement request may be generated by a user (such as a clinician,programmer, or patient) or by the system or other external device orindividual.

In step 1004, the light output is measured by the light monitor 124. Instep 1006, the calibration table(s) or calibration formula(s) is used todetermine the light output value from the light output measured by thelight monitor 124. In at least some embodiments using a calibrationtable(s), for light output measurements that are not provided on thetable, linear or non-linear interpolation or extrapolation techniquescan be used to determine the light output value. In step 1008, the lightoutput value is reported to the individual or device that made therequest.

It will be understood that each block of the flowchart illustrations,and combinations of blocks in the flowchart illustrations and methodsdisclosed herein, can be implemented by computer program instructions.These program instructions may be provided to a processor to produce amachine, such that the instructions, which execute on the processor,create means for implementing the actions specified in the flowchartblock or blocks disclosed herein. The computer program instructions maybe executed by a processor to cause a series of operational steps to beperformed by the processor to produce a computer implemented process.The computer program instructions may also cause at least some of theoperational steps to be performed in parallel. Moreover, some of thesteps may also be performed across more than one processor, such asmight arise in a multi-processor computer system. In addition, at leastone process may also be performed concurrently with other processes, oreven in a different sequence than illustrated without departing from thescope or spirit of the invention.

The computer program instructions can be stored on any suitablecomputer-readable medium including, but not limited to, RAM, ROM,EEPROM, flash memory or other memory technology, CD-ROM, digitalversatile disks (“DVD”) or other optical storage, magnetic cassettes,magnetic tape, magnetic disk storage or other magnetic storage devices,or any other medium which can be used to store the desired informationand which can be accessed by a computing device.

A system can include one or more processors that can perform the methods(in whole or in part) described above. The methods, systems, and unitsdescribed herein may be embodied in many different forms and should notbe construed as limited to the embodiments set forth herein.Accordingly, the methods, systems, and units described herein may takethe form of an entirely hardware embodiment, an entirely softwareembodiment or an embodiment combining software and hardware aspects. Themethods described herein can be performed using any type of processor orany combination of processors where each processor performs at leastpart of the process. In at least some embodiments, the processor mayinclude more than one processor.

The above specification provides a description of the manufacture anduse of the invention. Since many embodiments of the invention can bemade without departing from the spirit and scope of the invention, theinvention also resides in the claims hereinafter appended.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. An implantable optical stimulation system,comprising: an implantable light source; an implantable optical leadcoupled, or coupleable, to the implantable light source; at least one ofa calibration table or a calibration formula, wherein the at least oneof the calibration table or the calibration formula is predetermined andis generated by a calibration procedure specifically using theimplantable light source and the implantable optical lead of theimplantable optical stimulation system; and an implantable control unitcoupled, or coupleable, to the implantable light source and comprising amemory configured to store the at least one of the calibration table orthe calibration formula, and a processor coupled to the memory andconfigured for receiving a light intensity value at target tissue afteremission from the implantable optical lead and travel throughintervening tissue to the target tissue, using the at least one of thecalibration table or the calibration formula to determine at least oneoperational parameter for generating the light intensity value at thetarget tissue, wherein the calibration table or the calibration formulais based, at least in part, on an estimate of the light intensity valueat the target tissue, and directing the implantable light source, usingthe at least one operational parameter, to generate light to produce thelight intensity value at the target tissue.
 2. The implantable opticalstimulation system of claim 1, further comprising an implantable lightmonitor coupled, or coupleable to, the implantable control unit, whereinthe implantable optical lead further comprises a first optical waveguideconfigured to receive light generated by the implantable light sourceand emit the light from a distal portion of the implantable optical leadand a second optical waveguide configured to receive a portion of thelight emitted from the distal portion of the implantable optical leadand direct the received portion of the light to the implantable lightmonitor.
 3. The implantable optical stimulation system of claim 2,wherein the processor is further configured for receiving a measurementfrom the implantable light monitor in response to the generation oflight; and comparing the measurement to a target light output level toproduce the light intensity value at the target tissue.
 4. Theimplantable optical stimulation system of claim 3, wherein the processoris further configured for modifying the at least one operationalparameter based on the comparison between the measurement and the targetlight output level.
 5. The implantable optical stimulation system ofclaim 2, wherein the at least one of the calibration table or thecalibration formula comprises a relationship between measurement valuesof the implantable light monitor and light output values at the distalportion of the implantable optical lead.
 6. The implantable opticalstimulation system of claim 2, wherein the at least one of thecalibration table or the calibration formula comprises a relationshipbetween measurement values of the implantable light monitor and valuesof the at least one operational parameter.
 7. The implantable opticalstimulation system of claim 6, wherein the at least one operationalparameter is an amplitude of signal provided to the implantable lightsource to generate the light.
 8. The implantable optical stimulationsystem of claim 1, wherein the at least one of the calibration table orthe calibration formula comprises a relationship between light outputvalues at a distal portion of the implantable optical lead and values ofthe at least one operational parameter.
 9. The implantable opticalstimulation system of claim 8, wherein the at least one operationalparameter is an amplitude of signal provided to the implantable lightsource to generate the light.
 10. A non-transitory processor readablestorage media that includes instructions for optical stimulation usingan implantable optical stimulation system comprising an implantablelight source and an implantable optical lead, wherein execution of theinstructions by one or more processor devices of an implantable controlunit performs actions, comprising: receiving a light intensity value attarget tissue after emission from the implantable optical lead andtravel through intervening tissue to the target tissue, using the atleast one of the calibration table or the calibration formula todetermine at least one operational parameter for generating the lightintensity value at the target tissue, wherein the calibration table orthe calibration formula is predetermined and is based, at least in part,on an estimate of the light intensity value at the target tissue, anddirecting the implantable light source, using the at least oneoperational parameter, to generate light to produce the light intensityvalue at the target tissue.
 11. The non-transitory processor readablestorage media of claim 10, wherein the actions further comprisereceiving a measurement from the implantable light monitor in responseto the generation of light; and comparing the measurement to a targetlight output level to produce the light intensity value at the targettissue.
 12. The non-transitory processor readable storage media of claim11, wherein the actions further comprise modifying the at least oneoperational parameter based on the comparison between the measurementand the target light output value.
 13. A method of calibrating animplanted optical stimulation system comprising an implanted lightsource and an implanted optical lead, the method comprising: generatinglight using the implanted light source and different values of anoperational parameter; measuring a light output value for each of thedifferent values of the operational parameter; and generating at leastone of a calibration table or a calibration formula for the implantedoptical stimulation system using the measured light output values, thedifferent values of the operational parameter, and at least one of atissue absorption coefficient or a tissue diffusion coefficient.
 14. Themethod of claim 13, wherein the operational parameter is an amplitude ofsignal provided to the implanted light source to generate the light. 15.The non-transitory processor readable storage media of claim 11, whereinthe at least one of the calibration table or the calibration formulacomprises a relationship between measurement values of the implantablelight monitor and light output values at a distal portion of theimplantable optical lead.
 16. The non-transitory processor readablestorage media of claim 11, wherein the at least one of the calibrationtable or the calibration formula comprises a relationship betweenmeasurement values of the implantable light monitor and values of the atleast one operational parameter.
 17. The non-transitory processorreadable storage media of claim 16, wherein the at least one operationalparameter is an amplitude of signal provided to the implantable lightsource to generate the light.
 18. The method of claim 13, wherein the atleast one of the calibration table or the calibration formula comprisesa relationship between measurement values of an implanted light monitorand light output values at a distal portion of the implanted opticallead.
 19. The method of claim 13, wherein the at least one of thecalibration table or the calibration formula comprises a relationshipbetween measurement values of an implanted light monitor and values ofthe at least one operational parameter.
 20. The implantable opticalstimulation system of claim 2, wherein the at least one of thecalibration table or the calibration formula incorporates at least oneof a tissue absorption coefficient or a tissue diffusion coefficient.